Lead Medical Writer II — Phase I–IV Study Documents

Worldwide; Durham, Northern (NC, KY); Hybrid; USD 67,000 - 132,000; Full time

Job summary

Worldwide Clinical Trials seeks a Late Phase Medical Writer II to lead medical writing for Phase I–IV studies across USA, Europe and ROW. You will prepare protocols, amendments, ICFs, CTRs and Investigator Brochures, while coordinating reviews with Sponsors and internal teams in a fast-paced environment.

You will also develop region-specific documents like IMPDs and lay summaries, bring creative ideas to projects, and travel domestically and internationally as needed.

Qualifications

• University/college degree in life science or related allied health field.
• Minimum of 3 years of Medical Writing experience or equivalent.
• Willingness to travel domestically and internationally.

Responsibilities

• Prepare and lead the medical writing team on Phase I-IV study documents (protocols, amendments, informed consent, CTRs, narratives, Investigator Brochures).
• Prepare regional documents (e.g., IMPDs, lay summaries) outside the USA.
• Contribute creative ideas to add value to projects.
• Work independently or as part of a team.
• Coordinate internal and Sponsor document review cycles.
• Perform MW QC review of documents as needed.

Skills

Excellent written English

Project/time management

Independent work

Effective cross-functional沟通

Education

Bachelor's degree in life science or related field

Tools

Microsoft Word

PowerPoint

Excel

Outlook

Job description

Worldwide Clinical Trials seeks a Late Phase Medical Writer II to lead medical writing for Phase I–IV studies across USA, Europe and ROW. You will prepare protocols, amendments, ICFs, CTRs and Investigator Brochures, while coordinating reviews with Sponsors and internal teams in a fast-paced environment.

You will also develop region-specific documents like IMPDs and lay summaries, bring creative ideas to projects, and travel domestically and internationally as needed.